Pew Finds Serious Gaps in Oversight of U.S. Drug Safety

More medicines coming from developing countries, where oversight is lower

A former reporter and bureau chief for broadcast outlets and magazines, Truman Lewis has covered presidential campaigns, state politics and stories ranging from organized crime to environmental protection.
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Americans’ medicines are increasingly manufactured in developing countries, where there is less oversight than in the U.S., according to a new white paper by the Pew Health Group.

The U.S. Food and Drug Administration (FDA) estimates 40 percent of finished drugs and 80 percent of active ingredients and bulk chemicals used in U.S. drugs come from overseas.

The white paper finds that increased outsourcing of manufacturing, a complex and globalized supply chain and criminal actors create the potential for counterfeit or substandard medicines to enter the supply chain and reach patients.

For economic reasons, the migration of manufacturing abroad is likely to continue. But industry and government agencies have failed to adapt to the changing environment, the report finds

“Today’s prescriptions are being produced under last century’s oversight,” said Allan Coukell, director of medical programs at the Pew Health Group. “Compared with a decade ago, pharmaceutical supply lines stretch around the world and out to a complex web of suppliers.

"Regulators and industry must modernize supervision of the manufacturing process to ensure the drugs we consume are safe. The After Heparin white paper indentifies links in the supply chain that government and business should strengthen,” Coukell said.

Substandard or adulterated pharmaceutical materials from abroad have entered the U.S. on multiple occasions. In addition, the risks of domestic counterfeiting and diversion of stolen drugs are well documented.

The white paper presents several case studies, including incidents involving heparin, a blood thinner adulterated during its manufacture in China, counterfeit vials of the anemia drug Epogen and stolen vials of insulin to illustrate the threats and suggest solutions.

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